The news about the spread of COVID-19 has been awful of late, with record numbers of people catching the disease. But thanks to the CARES Act, the US government is throwing $2.2 trillion at this ginormous problem, and improvements in science and manufacturing hopefully will result.
The CARES Act funded the expansion of unemployment benefits and research efforts toward understanding, preventing, and curing COVID-19. Less discussed is the funding it’s providing to help expand the manufacturing needed to produce items related to healthcare and a COVID-19 vaccine for 300 million Americans.
The CARES Act gives $27.0 billion to the Department of Health and Human Services to fund activities that include developing and purchasing vaccines and therapeutics, according to a June 25 Government Accountability Office report.
At least $3.5 billion of the funding is earmarked for the Biomedical Advanced Research and Development Authority (BARDA). Public Citizen does a nice job of breaking out what companies are getting what grants.
As we mentioned in last Thursday’s Morning Briefing, Becton Dickinson received $42.3 million from BARDA to expand its production of needles and syringes as part of the program.
Here’s a quick look at some of the BARDA’s grants relating to the manufacturing of goods needed to fight COVID-19. They hopefully will strengthen the domestic production of pharmaceuticals for years to come.
(1) Lots of needles and vials needed. In addition to Becton Dickinson’s funding, the agency is also giving $20.7 million to Smiths Medical and another $53.7 million to Retractable Technologies to fund the expansion of manufacturing of safety needles and syringes.
Corning was granted $204.0 million to expand its domestic manufacturing of Corning Valor Glass tubing and vials/cartridges. And Si02 received $143.0 to develop/establish three US-based manufacturing systems for durable, high-performance glass/plastic vials.
BARDA has also focused on the materials going into the vaccines. It gave $31 million to Cytiva to expand the company’s manufacturing capacity for products used to produce COVID-19 vaccines. The products include liquid and dry powder cell culture media, cell culture buffers, mixer bags, and XDR bioreactors, an October 13 press release states. BARDA has awarded Snapdragon Chemistry $691,878 to help develop an “innovative continuous manufacturing platform to produce ribonucleotide triphosphates (NTPs), a critical raw material for COVID-19 vaccines that use messenger RNA technology,” a June 11 press release states.
(2) Gotta fill the vials. Vaccine developers typically hire their own fill finish facilities for their vaccines. But the US government is reserving capacity to ensure that COVID-19 vaccine producers have access to this capacity. It’s also giving them money to expand their capacity.
Ology Bioservices received $106.3 million from BARDA to reserve production capacity to fill and finish about 15.6 million vials. Grand River Aseptic was given $1.6 million to expand capacity for filling and finishing vaccines and therapeutics. And Thermo Fisher Scientific received $49.2 million to expand its US facilities designed to fill individual vaccine doses under sterile conditions at high volumes.
Emergent BioSolutions won a $628 million contract with the government, most of which will be used to produce COVID-19 vaccines through 2021 and $85.5 million of which will be used to expand Emergent’s vial-filling contract development and manufacturing capacity for vaccines and therapeutics.
Similarly, BARDA gave $264.7 million to the Texas A&M University System’s Center for Innovation in Advanced Development and Manufacturing to reserve vaccine production capacity through 2021 and to “more rapidly expand production capacity for vaccine manufacturing” at their Texas facility, a July 27 press release stated.
(3) Planning beyond COVID-19. With many US drugs and drug ingredients made in China and other countries, the US government seems focused on beefing up US production. As we discussed in the May 7 Morning Briefing, politicians on both sides of the aisle understand that the ability to manufacture drugs domestically is a matter of domestic security.
Some of the funds earmarked to bolster the US manufacturing of pharmaceuticals is coming from BARDA. The agency entered into a $354 million contract with Phlow Corp. to build a generic medicine and API plant in Richmond, VA and to supply COVID-19 treatments produced there. The deal can expand to 10 years and $812 million.
BARDA also gave Paratek $285 million to build a second supply chain to make Nuzyra, an antibiotic, in the US. Its current supply line is in Europe. The funding will also go toward studying whether Nuzyra can be used to fight anthrax infection. The five-year agreement requires the company to give the US Strategic National Stockpile 10,000 treatment courses of Nuzrya.
“[T]he drug maker will onshore production of Nuzyra's active pharmaceutical ingredient (API) from U.S.-sourced raw materials,” a June 8 article in Fierce Pharma reported. “The move to build its U.S. supply will come with ‘incremental costs’ of doing business, including higher wages and more stringent demands from BARDA, but Paratek is aiming to mitigate those new costs with a more streamlined production network.”
“‘We probably would not have been able to go to the U.S. based on the incremental costs unless we had this public-private partnership with BARDA,” CEO Evan Loh told Fierce Pharma.
Dr. Ed Yardeni is the president of Yardeni Research, Inc., a provider of independent global investment strategy research.
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